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Topical AS101 for Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women

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ClinicalTrials.gov Identifier: NCT00418249
Recruitment Status : Unknown
Verified December 2006 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 4, 2007
Last Update Posted : January 4, 2007
Sponsor:
Information provided by:
Rabin Medical Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary objective of this study is to assess the safety and efficacy of topical AS101 as treatment for Female Androgenetic Alopecia (FAGA) in menopause women.

Condition or disease Intervention/treatment Phase
Alopecia Drug: AS101 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 2 Study of Topical AS101 for the Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. hair density

Secondary Outcome Measures :
  1. Hair diameter, anagen/telogen ratio and hair growth rate,Global photographic assessment according to Female-Ludwig scale,
  2. Self-administered satisfaction questionnaire

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women in menopause, over 50 years of age.
  • Clinically diagnosed for AGA, according to Ludwig scale I-II.

Exclusion Criteria:

  • Women treated with chronic medications.
  • Use of Minoxidil within 3 months prior to entering study.
  • Women who have underwent hair transplantation.
  • Use of drugs with androgenic or anti-androgenic effects.
  • Any other type of hair loss.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418249


Contacts
Contact: Danny Ben Amitai, MD 972-3-9253770
Contact: Raziel Lurie, MD rlurie@bezeqint.net

Locations
Israel
Not yet recruiting
Tel Aviv, Israel
Contact: Danny Ben Amitai    972-3-9253770      
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Danny Ben-Amitai, M.D. Rabin Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00418249     History of Changes
Other Study ID Numbers: #69 REV 00
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: January 4, 2007
Last Verified: December 2006

Keywords provided by Rabin Medical Center:
Androgenetic Alopecia
Telogen effluvium
Chronic telogen effluvium
Menopause
Female Androgenetic Alopecia (FAGA)

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Ammonium trichloro(dioxoethylene-O,O'-)tellurate
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Radiation-Protective Agents
Protective Agents